【摘要】 目的:建立复方麻黄甘油剂的定性鉴别方法和含量测定方法,确定质量标准。方法:采用薄层色谱(TLC)法对复方麻黄甘油剂中的麻黄和苦参进行定性鉴别,采用高效液相色谱(HPLC)法对麻黄成分盐酸麻黄碱和盐酸伪麻黄碱进行含量测定。在HPLC测定中,以十八烷基硅烷键合硅胶为填充剂,以乙腈-0. 1%磷酸溶液(5∶95)为流动相,检测波长为210 nm,流速1. 0 ml/min,温度30℃,进样量20μl。结果:TLC图谱斑点清晰,分离度高。在HPLC测定中,盐酸麻黄碱、盐酸伪麻黄碱的进样浓度线性范围分别为0. 3000～1. 5000μg/ml(r=0. 9986)、0. 1450～0. 7250μg/ml(r=0. 9957),平均回收率分别为98. 23%(RSD=0. 29%,n=6)、98. 28%(RSD=0. 40%,n=6),精密度、稳定性、重复性试验的RSD均小于0. 4%(n=6)。结论:该定性和定量方法准确可靠,为复方麻黄甘油剂的制剂生产和临床应用提供质量保证。更多还原

【Abstract】 Objective: To develop the qualitative identification and content measurement methods for compound ephedra glycerin,and subsequently establish the quality standards. Methods: Thin layer chromatography( TLC) method was used to qualitatively identify the ephedra and radix sophorae flavescentis in the compound ephedra glycerin. High performance liquid chromatography( HPLC) method was carried out to measure the contents of major ephedra constituents including ephedrine hydrochloride and pseudoephedrine hydrochloride. In the HPLC measurement,octadecylsilane bonded silica was used as filler and phosphoric acid solution( 5 ∶ 95) containing0. 1% acetonitrile as mobile phase. The detection wavelength is 210 nm,the flow rate is 1. 0 ml/min,the temperature is 30 ℃,and the injection volume is 20 μl. Results: The TLC spectrum shows clear spots and high resolution. For the HPLC measurement, the injection concentration ranges of ephedrine hydrochloride and pseudoephedrine hydrochloride that show linear relationships are 0. 3000 ～ 1. 5000 μg/ml( R2= 0. 9986) and 0. 1450 ～ 0. 7250μg/ml( R2= 0. 9957),respectively. The average recovery rates are 98. 23%( RSD( relative standard deviation) =0. 29%,n = 6) and 98. 28%( RSD = 0. 40%,n = 6),respectively. The RSDs of precision,stability and repeatability are all less than 0. 4%( n = 6). Conclusion: The qualitative identification and quantitative measurement methods are accurate and reliable,which are proved to be able to provide quality assurance for products preparation and clinical application.更多还原